Focused On Health Care Law

Pandemic-related DEA compliance

| May 21, 2021 | Regulatory compliance |

The potential for abuse and addiction involving controlled substance medications makes it of paramount importance for doctors, pharmacies, hospitals and other health care providers to comply with laws and regulations enforced by the federal government’s Drug Enforcement Administration (DEA).

Providers that administer and dispense controlled substance medications have dealt with unprecedented challenges over the past year, but the challenge to be DEA-compliant remains unchanged. However, the agency has issued guidelines related to pandemic-specific vaccines and other matters that add to the compliance burden.

Here are areas of concern for providers to be aware of as we all continue to make our way through this public health crisis.

Telemedicine prescriptions

Because of the rapid expansion of telemedicine during the pandemic, practitioners are authorized to prescribe certain controlled substance medications without in-person evaluations. Of course, those prescriptions must all be for legitimate medical purposes and issued in compliance with pertinent state and federal laws.

Five-percent rule exceptions

Registered providers are temporarily allowed to supply other registered providers with more than five percent of their dosage units. The DEA expects providers to be aware of when the exception expires. (Note: it expires when the public health emergency ends or the DEA modifies the exception.)

Inventory management

Documentation of prescription drug inventory management is always important for DEA registrants, but even more so for providers utilizing the exception to the five-percent rule. Comprehensive documentation of who got what when will demonstrate compliance.

Note: in a DEA audit or inspection, the ability to demonstrate compliance with recordkeeping, storage and disposal regulations is in many ways as important as being compliant.

Prescription opioid diversion

Doctors, pharmacies and other providers must have rigorous policies and procedures to specifically address possible opioid diversion.